Edrophonium

As a rare disorder of neuromuscular junction transmission, myasthenia gravis has long lacked fast-acting assessment drugs for clinical diagnosis and crisis differentiation. As a short-acting reversible acetylcholinesterase inhibitor, edrophonium chloride can reduce the degradation of acetylcholine by inhibiting cholinesterase activity and temporarily enhance the conduction function of the neuromuscular junction. It takes effect 30 to 60 seconds after intravenous injection and the effect lasts for about 10 minutes. It is a core first-line drug for the diagnosis of myasthenia gravis and the differentiation between myasthenic crisis and cholinergic crisis. It can also be used to reverse the postoperative residual effect of non-depolarizing muscle relaxants, and the applicable population covers patients with suspected myasthenia gravis and surgical patients requiring muscle relaxation antagonism during the perioperative period.

At present, the global market size of edrophonium chloride is approximately USD 120 million. Driven by the increase in the diagnosis rate of rare diseases and the growing demand for perioperative muscle relaxation antagonism, the compound annual growth rate in the past 3 years has remained at 6.8%. The domestic market is currently in a stage of supply gap. Due to the relatively niche clinical demand and high threshold of production technology, only a small number of enterprises have deployed the R&D of the API and preparations of this variety. The overall market competition is low, and it has not been included in the scope of national centralized volume procurement. Suppliers with mature and compliant production capacity have relatively high market entry advantages.

The original research enterprise of edrophonium chloride is Baxter Healthcare, and the original research brand name is Enlon. The core compound patent in the United States expired in 1988, and there is no patent restriction in the main current market. The dosage form approved by the original research is injection, with specifications including 10mg/1mL and 100mg/10mL. It has been included in the FDA Orange Book Reference Listed Drug Catalog, but has not been included in the China Listed Drug Catalog. As of the retrieval time point, there is no edrophonium chloride API that has been registered with the CDE in China, nor is there any domestic edrophonium chloride preparation variety approved for marketing. The clinical demand can only be met through a small number of import channels. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity standards for edrophonium chloride API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable impurity reference substance support for relevant R&D and production enterprises, accelerating the registration and declaration progress of the variety.